The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain

NCT ID: NCT05791513

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2025-04-26

Brief Summary

The aim of the stepped-wedge cluster randomised trial is to investigate the effectiveness of using a clinical support tool (The MAP-Knee Tool) in managing adolescents aged 10-19 years with non-traumatic knee pain compared to not using the tool. Six participating hospitals will start to use the tool within 4, 6, or 8 months after recruitment start in a randomised order. We will investigate if using the tool is superior in terms of reducing symptoms compared to not using the tool.

Detailed Description

The trial will be designed as a stepped-wedge cluster randomised superiority trial to be conducted across 6 hospital departments across Denmark. Any orthopaedic or similar hospital department in Denmark to which adolescents suffering from non-traumatic knee pain may be referred is eligible for participation. Any medical doctor or physiotherapist employed at either of the study sites who regularly see adolescents with non-traumatic knee pain will be eligible to participate in the trial.

Before crossover occurs at the study site, the adolescents will be treated as usual which is at the discretion of the treating clinician. Based on our current research on the usual care pathway, this will be heterogenous and include advice to wait and see, imaging (most often MRI and x-ray), or a rehabilitation plan for the municipality. After crossing over to using the MAP-Knee Tool, the treating clinician will use the MAP-Knee Tool together with the adolescent. The tool was designed to support the entire consultation from diagnosing the condition (patellofemoral pain, Osgood-Schlatter, Sinding-Larsson-Johansson, growth pain, patellar tendinopathy, or iliotibial band syndrome) to deciding on future management. The MAP-Knee Tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis, and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence. After the initial prototype of the tool including all four components had been made, the investigators performed end-user testing using think-aloud sessions with adolescents suffering from non-traumatic knee pain, adolescents with no history of knee pain, and medical doctors.

Conditions

Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Using the MAP-Knee Tool

The treating clinician will use the MAP-Knee Tool together with the adolescent. The tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis(19), and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence.

Group Type: EXPERIMENTAL

Using the MAP-Knee Tool

Intervention Type: OTHER

Using the MAP-Knee Tool

Not using the MAP-Knee Tool

The treating clinician will not use the MAP-Knee Tool in the consultation and will conduct the consultation as per usual practice.

Group Type: ACTIVE_COMPARATOR

Usual practice

Intervention Type: OTHER

The consultation between clinician and adolescent is conducted as per usual practice.

Interventions

Using the MAP-Knee Tool

Using the MAP-Knee Tool

Intervention Type: OTHER

Usual practice

The consultation between clinician and adolescent is conducted as per usual practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having been referred to a hospital due to non-traumatic knee pain
• Age between 10 and 19 years

Exclusion Criteria

• Knee pain with a traumatic origin
• Lack of ability to cooperate

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Michael Skovdal Rathleff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg Universitetshospital

Aalborg, , Denmark

Amager-Hvidovre Hospital

Copenhagen, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Sportsmedicinsk Center

Frederikshavn, , Denmark

Næstved Sygehus

Næstved, , Denmark

Vejle Sygehus

Vejle, , Denmark

Countries

Denmark

Other Identifiers

N-20220043

Identifier Type: -

Identifier Source: org_study_id